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Prevention of Serious Adverse Events in Acute Care Hospitals by Afferent Limb and Response Method Intervention - the ALARM Intervention Study. (ALARM)

Primary Purpose

Unexpected Hospital Mortality, Death, Sudden, Cardiac, Unplanned Intensive Care Unit Admission

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
ALARM intervention
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Unexpected Hospital Mortality

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All patients admitted to the partaking wards during the study period (October 1st 2013 - September 30th 2015)

Exclusion Criteria:

  • Age: ≤ 16

Sites / Locations

  • University of Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ALARM intervention

Control group

Arm Description

The training of nursing and medical staff about the observation, detection, assessment and communication of deteriorating and critically ill patients and the introduction of a standardized observation and communication protocol on medical and surgical wards.

Outcomes

Primary Outcome Measures

In-hospital unexpected death
Unplanned ICU admission
Cardiac arrest

Secondary Outcome Measures

Full Information

First Posted
September 17, 2013
Last Updated
April 24, 2017
Sponsor
Universiteit Antwerpen
Collaborators
Belgian Federal Public Service, Food Chain Safety and Environment
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1. Study Identification

Unique Protocol Identification Number
NCT01949025
Brief Title
Prevention of Serious Adverse Events in Acute Care Hospitals by Afferent Limb and Response Method Intervention - the ALARM Intervention Study.
Acronym
ALARM
Official Title
Prevention of Serious Adverse Events in Acute Care Hospitals by Afferent Limb and Response Method Intervention - the ALARM Intervention Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
Belgian Federal Public Service, Food Chain Safety and Environment

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Summary Growing evidence suggests that a significant proportion of in-hospital patient deaths occur after serious adverse events (SAE's). Concerns have been raised that too often patients' acute deteriorations, particularly on surgical and medical wards outside critical care settings, are identified too late and corrective actions taken too slowly. Many initiatives have been taken to prevent unexpected death by timely recognition, intervention and resuscitation efforts such as Rapid Response Systems (RRS's). RRS's have been introduced with the intention to prevent SAE's and to improve patient outcome by facilitating early detection of warning signs for clinical deterioration. These systems have four components (1) an afferent limb for detection and response triggering, (2) an efferent limb with medical or nursing response to prevent deterioration (3) a process improvement limb and (4) a governance and administrative structure. It remains uncertain which elements of RRS's contribute most to patient outcomes such as unplanned (re-) admission to the intensive care unit, shock, cardiac arrest and unexpected death. In addition, previous studies found that nurse observation, assessment and communication (afferent limb) are crucial to achieve better patient outcomes, but how to achieve afferent limb sustainability in hospitals is not clear. A previous study investigated 23 hospitals in Flanders (Belgium) about how nurses observe, assess, detect and communicate deteriorating and critical patients in surgical, medical and geriatric wards. Wide variation between hospitals was identified about critical patient intervention procedures, strategies and Do Not Attempt Resuscitation (DNAR) orders as well as between nurses about the use and knowledge of critical vital signs and call criteria for physician clinical advice and support. Nurses of hospitals with structured observation and communication protocols were better informed and perceived their communication and collaboration with physicians more favorable in compared to other hospitals. Based on these results conclusions and recommendations for further initiatives were formulated. The proposed Afferent Limb and Response Method intervention study will implement these recommendations guided by a robust scientific research approach to offer evidence to the nursing and medical practice community. The aim of this study is to evaluate the effect of the Afferent Limb Ascertainment and Response Method intervention or ALARM intervention in medical and surgical nursing wards of acute care hospitals on the prevention of SAE's such as in-hospital unexpected death, unplanned ICU-admission and cardiac arrest. Study hypothesis Optimizing and supporting the process of observation, use and interpretation of vital signs, detection, assessment, escalation and communication with a higher level of care in deteriorating patients can prevent serious adverse events (in-hospital unexpected death, unplanned ICU admission and cardiac arrest) in acute care hospitals.
Detailed Description
- What does the study involve? The study is based on the application of training and tools: the training of nursing and medical staff about the observation, detection, assessment and communication of deteriorating and critically ill patients and the introduction of a standardized observation and communication protocol on medical and surgical wards (tools). A training team will offer standardized training sessions. - When does the study take place? From October 1st 2013 till September 30th 2015. - Where does the study take place? Belgium. - What are the risks to participants? Patients will not be exposed to complementary risks if they partake in this study. No additional investigations will be performed for the purpose of this study since the aim of the intervention is to optimize existing processes that are already used in a hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unexpected Hospital Mortality, Death, Sudden, Cardiac, Unplanned Intensive Care Unit Admission

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69656 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALARM intervention
Arm Type
Experimental
Arm Description
The training of nursing and medical staff about the observation, detection, assessment and communication of deteriorating and critically ill patients and the introduction of a standardized observation and communication protocol on medical and surgical wards.
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
ALARM intervention
Intervention Description
The training of nursing and medical staff about the observation, detection, assessment and communication of deteriorating and critically ill patients and the introduction of a standardized observation and communication protocol on medical and surgical wards.
Primary Outcome Measure Information:
Title
In-hospital unexpected death
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Unplanned ICU admission
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Cardiac arrest
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients admitted to the partaking wards during the study period (October 1st 2013 - September 30th 2015) Exclusion Criteria: Age: ≤ 16
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip Haegdorens, RN, MScN, PhD Candidate
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Van Bogaert, RN, MA, PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Koenraad G. Monsieurs, MD, PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Koen De Meester, RN, MScN, PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Study Chair
Facility Information:
Facility Name
University of Antwerp
City
Wilrijk
State/Province
Antwerp
ZIP/Postal Code
2610
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
24011975
Citation
De Meester K, Haegdorens F, Monsieurs KG, Verpooten GA, Holvoet A, Van Bogaert P. Six-day postoperative impact of a standardized nurse observation and escalation protocol: a preintervention and postintervention study. J Crit Care. 2013 Dec;28(6):1068-74. doi: 10.1016/j.jcrc.2013.07.061. Epub 2013 Sep 6.
Results Reference
background
PubMed Identifier
31012124
Citation
Haegdorens F, Monsieurs KG, De Meester K, Van Bogaert P. An intervention including the national early warning score improves patient monitoring practice and reduces mortality: A cluster randomized controlled trial. J Adv Nurs. 2019 Sep;75(9):1996-2005. doi: 10.1111/jan.14034. Epub 2019 Jun 6.
Results Reference
derived
Links:
URL
http://www.alarmstudy.be
Description
Related Info

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Prevention of Serious Adverse Events in Acute Care Hospitals by Afferent Limb and Response Method Intervention - the ALARM Intervention Study.

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